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A Clinical and Histopathological Study of the Intrathoracic Application and Resorption of Cotton-derived Oxidized Cellulose Hemostatic Gauze
Biruta Witte1, Stefan Gross1, Stefan M. Kroeber2, Michael Wolf1, Hubertus Hillebrand1, Martin Huertgen1.
1Katholisches Klinikum Koblenz-Montabaur, Koblenz, Germany, 2Institute of Pathology, Koblenz, Germany.
OBJECTIVE: Pilot clinical human in-vivo study of the intrathoracic application of a cotton-derived oxydized cellulose gauze with regard to resorption, clinical performance and safety.
METHODS: Prospective non-comparative observational study with the primary endpoint defined as the local presence of gauze remnants, fluid collections and adhesions, and a secondary safety endpoint defined as the number of adverse events and surgical re-interventions. For this purpose, a defined amount of gauze was inserted in the subcarinal space of patients with resectable lung carcinoma at staging videoassisted mediastinoscopic lymphadenectomy, and re-examined several days later at subsequent lung resection for macroscopic and histologic evaluation.
RESULTS: 25 consecutive patients were included from June 2008 to January 2009. The desired hemostatic effect was achieved in all cases. No adverse events were observed. At reexploration, the subcarinal space appeared clean and free of inflammatory changes and scars. The residuals of oxidized cellulose were losing their solid structure five days after insertion, and were last detected two weeks after after insertion.
CONCLUSIONS: The mediastinal application of cotton-derived oxydized cellulose is safe and effective. A piece of gauze measuring 5 x 20 cm is absorbed completely within 14 days. Beyond the known hemostatic effect, the absence of inflammation, and the reduced formation of seroma and adhesions are of surgical interest and should be confirmed by a larger comparative study.
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